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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Assisted Reproduction
510(k) Number K990350
Device Name WALLACE CATHETERS-18CM, MODEL 1816; 23CM, MODEL 1816N; 23CM, MODEL 2316
Applicant
Coopersurgical Inc.,
15 Forest Pkwy.
Shelton,  CT  06484
Applicant Contact DEBRA A PEKAR
Correspondent
Coopersurgical Inc.,
15 Forest Pkwy.
Shelton,  CT  06484
Correspondent Contact DEBRA A PEKAR
Regulation Number884.6110
Classification Product Code
MQF  
Date Received02/05/1999
Decision Date 07/26/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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